Understanding and Preventing Cortical Mechanisms of Chemotherapy-induced Peripheral Neuropathy

Recruiting

• Conditions: Chemotherapy-induced Peripheral Neuropathy
• Interventions: Diagnostic Test: Electroencephalogram (EEG)

• Registration Number: NCT06389721
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

Cohort 1: To track the onset and progression of a condition called chemotherapy-induced peripheral neuropathy (CIPN).

Cohort 2: To track the onset and progression of a condition called chemotherapy-induced peripheral neuropathy (CIPN) and to test a certain type of experimental neuromodulation (stimulation of the brain) with a device called a closed-loop brain-computer interface (clBCI) to see if can help to prevent pain due to CIPN.

Detailed Description

Primary Objectives:

Objective 1 (Primary Objective): to examine preliminary baseline and serial electrophysiological markers associated with the onset and development of CIPN by tracking brain activity and CIPN symptoms throughout chemotherapy treatment.

Secondary Objectives:

Objective 2 (Secondary Objective): To preliminarily evaluate whether a clBCI program can regulate changes in EEG that are associated with CIPN while participants are undergoing chemotherapy.

Exploratory Objective: Explore whether there are associations between change in brain function and subjective report of CIPN.

Study Timeline

• Study First Submitted: 2024-04-25
• Study First Submitted QC: 2024-04-25
• Study First Posted: 2024-04-29
• Study Start: 2024-07-16
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-02
• Last Update Posted: 2025-05-04
• Primary Completion: 2027-01-31
• Study Completion: 2027-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 1	Electroencephalogram (EEG)	Participants in Group 1, you will have an EEG and complete one questionnaire prior to your first dose of chemotherapy and once monthly until the end of your chemotherapy (for a maximum of 6 measurements).
Cohort 2	Electroencephalogram (EEG)	Participants in Group 2, you will have an EEG, and complete a questionnaire before and after your chemotherapy regimen. Participants will also have a treatment called closed-loop brain-computer interface (clBCI) training twice a week for the 2 weeks leading up to starting chemotherapy, and then twice a week during chemotherapy, for a maximum of 32 sessions, which you will be able to do at home.

Primary Outcome Measures

Name	Time	Method
Safety and adverse events (AEs)	Through study completion; an average of 1 year.	Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Trial Locations

Locations (1)

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States